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Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis

Primary Purpose

End-Stage Kidney Disease, Hemolysis, Nursing

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluid Distribution Timetable
Sponsored by
University of Santo Tomas Hospital, Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End-Stage Kidney Disease focused on measuring Fluid distribution timetable, Fluid restriction adherence, End-Stage Kidney Disease, Hemodialysis, Thirst, Interdialytic Weight Gain, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who were diagnosed with end stage renal disease (ESRD);
  • were oligoanuric (oliguria of <1mL/kg/hour or anuria over 6 hours);
  • had been on hemodialysis for at least 6 months;
  • were alert and oriented; and,
  • were scheduled for hemodialysis twice a week

Exclusion Criteria:

  • Patients who were pregnant;
  • had a history of or has overt mental illness;
  • were lethargic, disoriented, or debilitated during recruitment; and,
  • had complicated medical conditions such as congestive heart failure and pulmonary congestion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Fluid Distribution Timetable (FDT) Group

    Comparison Group

    Arm Description

    It is the fluid distribution timetable. It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.

    It is the standard of care that served as the intervention. The control group received the standard care for patients on hemodialysis. The standard care involves a 10 -15-minute face-to-face health teaching of their treatment regimen including pharmacologic management, dialysis schedule, dietary and fluid restrictions or nutritional therapy, care for vascular access, and other necessary lifestyle modifications.

    Outcomes

    Primary Outcome Measures

    Perceived Thirst
    The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst.
    Interdialytic Weight Gain
    It is the net increase in body weight from previous post-dialysis weight measured in kilograms

    Secondary Outcome Measures

    Age
    It refers to the age of the respondent in years at the time of participation in the study.
    Sex
    It refers to the biological gender assignment of the respondent at the time of participation in the study.
    Educational Attainment
    It refers to the highest educational attainment of the respondent and it is categorized into 5: no formal education, primary education, secondary education, college level, and post-graduate level.
    Blood Pressure
    It refers to both the systolic and diastolic blood pressure, measured in mmHg, of the respondent.
    Pulse Rate
    It refers to the number of heart beats per minute.
    Respiratory Rate
    It refers to the number of respirations in minute of the respondent.
    Edema Status
    This refers to the edema status of the respondent at the time of participation in the study.
    Ultrafiltration Goal
    It refer to the ultrafiltration status of the respondent and it is categorized into to: met goal and unmet goal.

    Full Information

    First Posted
    June 15, 2018
    Last Updated
    June 27, 2018
    Sponsor
    University of Santo Tomas Hospital, Philippines
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03582592
    Brief Title
    Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis
    Official Title
    Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease Undergoing Hemodialysis: A Single-Blind, Randomized-Controlled Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2016 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Santo Tomas Hospital, Philippines

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Fluid restriction is necessary among patients with chronic kidney disease. However, treatment adherence remains a challenge. Hence, this study determined the effects of a fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing hemodialysis. This study used a single-blind, randomized-controlled pilot study design. Patients with end-stage renal disease were randomly-assigned using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the fluid distribution timetable or standard care. Adherence to fluid restriction was measured using two indicators - thirst and interdialytic weight gain - and were compared using One-way RM-MANOVA and MANCOVA. Secondary outcomes included baseline patient demographic and clinical characteristics and were compared according to treatment allocation. Both groups were followed-up for four weeks, assessing outcome measures during the second hemodialysis session for each week.
    Detailed Description
    End-stage renal disease (ESRD), defined as a condition in which the kidneys are damaged or cannot filter blood similar to a healthy kidney (Centers for Disease Control and Prevention, 2017), is a rising global dilemma. In fact, it has been a leading cause of morbidity and mortality worldwide, afflicting approximately 8% - 16% of the global population (Jha et al., 2013) and ranking eighth among the leading causes of death. It has also been acknowledged as a troublesome disorder causing a myriad of health-related problems (Lowney et al., 2015), financial burden (Bavanandan et al., 2016), and poor survival outcomes (Halle et al., 2016). Hemodialysis, a form of renal replacement treatment, has been the mainstream management for patients with kidney diseases (Smeltzer et al., 2010) despite several health complications (Smeltzer et al., 2010; Lowney et al., 2015). However, dietary and fluid therapy are also necessary components of the management for patient with ESRD. A common concern among patients on hemodialysis is the non-adherence to fluid therapy. Although this management is simple, it remains a challenge to patients on hemodialysis because of several physiologic changes brought by ESRD. As a result, numerous problems such as fluid overload, electrolyte imbalances, and acid-base imbalances occur which are detrimental to the patient's overall health. Since patients on hemodialysis are the key players in promoting their health, it is, therefore, imperative to develop individualized and empowering strategies what will promote their adherence to fluid therapy. The proposed strategy in this study is the fluid distribution timetable, a simple and health promotive intervention involving scheduled distribution of pre-determined amounts of fluid intake on a daily basis. This intervention consider the various sources and usage of fluids per day and allocates fluid intake according to the patient's prescribed fluid restriction. Hence, this study determined the effects of a fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing hemodialysis. This study is a single-blind, single-center, randomized-controlled pilot study at the dialysis unit of a tertiary level government-owned institution in Quezon City, Philippines. Patients were randomly-allocated to receive fluid distribution timetable with standard care (intervention) or standard care alone (control). Random allocation of respondents was conducted using computer-generated sequences of randomly permuted blocks (sizes of three, four, and five) at our office. Randomization was carried out by an independent statistician and was stratified according to their sex. During the study period, treatment allocation was masked from site personnel and patients. Post-hoc power analysis for two group means, using GPower version 3.1, revealed that a sample size of 24 patients with a 1:1.20 group allocation ratio yields a power of 99% at a significance of 5% (two-sided) and detects an effect size of 0.80. The control group received the standard care for patients on hemodialysis. The standard care involves a 10 -15-minute face-to-face health teaching of their treatment regimen including pharmacologic management, dialysis schedule, dietary and fluid restrictions or nutritional therapy, care for vascular access, and other necessary lifestyle modifications. The treatment group, on the other hand, received a combination of the standard care and the intervention, the fluid distribution timetable. It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters. In designing the intervention, we selected three behavior-specific cognitions from the Health Promotion Model by Nola J. Pender: perceived benefits, barriers, and self-efficacy. These cognitions are modifiable determinants of behavior that promote well-being. As such, the fluid distribution timetable enumerated the advantages of adherence and the disadvantages of non-adherence to fluid restriction. Adherence to fluid restriction was measured using two indicators - thirst and interdialytic weight gain - and were compared using One-way RM-MANOVA and MANCOVA. Thirst was measured using a self-reported questionnaire the Dialysis Thirst Inventory, while interdialytic weight gain computed using a calibrated calculator by subtracting post-dialysis weight at the end of the previous hemodialysis session from the pre-dialysis weight during the current hemodialysis session. Secondary outcomes included baseline patient demographic and clinical characteristics and were compared according to treatment allocation. Both groups were followed-up for four weeks, assessing outcome measures during the second hemodialysis session for each week.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End-Stage Kidney Disease, Hemolysis, Nursing
    Keywords
    Fluid distribution timetable, Fluid restriction adherence, End-Stage Kidney Disease, Hemodialysis, Thirst, Interdialytic Weight Gain, Nursing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluid Distribution Timetable (FDT) Group
    Arm Type
    Experimental
    Arm Description
    It is the fluid distribution timetable. It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.
    Arm Title
    Comparison Group
    Arm Type
    No Intervention
    Arm Description
    It is the standard of care that served as the intervention. The control group received the standard care for patients on hemodialysis. The standard care involves a 10 -15-minute face-to-face health teaching of their treatment regimen including pharmacologic management, dialysis schedule, dietary and fluid restrictions or nutritional therapy, care for vascular access, and other necessary lifestyle modifications.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Fluid Distribution Timetable
    Intervention Description
    It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.
    Primary Outcome Measure Information:
    Title
    Perceived Thirst
    Description
    The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst.
    Time Frame
    4 Weeks
    Title
    Interdialytic Weight Gain
    Description
    It is the net increase in body weight from previous post-dialysis weight measured in kilograms
    Time Frame
    4 Weeks
    Secondary Outcome Measure Information:
    Title
    Age
    Description
    It refers to the age of the respondent in years at the time of participation in the study.
    Time Frame
    Week 1
    Title
    Sex
    Description
    It refers to the biological gender assignment of the respondent at the time of participation in the study.
    Time Frame
    Week 1
    Title
    Educational Attainment
    Description
    It refers to the highest educational attainment of the respondent and it is categorized into 5: no formal education, primary education, secondary education, college level, and post-graduate level.
    Time Frame
    Week 1
    Title
    Blood Pressure
    Description
    It refers to both the systolic and diastolic blood pressure, measured in mmHg, of the respondent.
    Time Frame
    4 Weeks
    Title
    Pulse Rate
    Description
    It refers to the number of heart beats per minute.
    Time Frame
    4 Weeks
    Title
    Respiratory Rate
    Description
    It refers to the number of respirations in minute of the respondent.
    Time Frame
    4 Weeks
    Title
    Edema Status
    Description
    This refers to the edema status of the respondent at the time of participation in the study.
    Time Frame
    Week 1
    Title
    Ultrafiltration Goal
    Description
    It refer to the ultrafiltration status of the respondent and it is categorized into to: met goal and unmet goal.
    Time Frame
    Week 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who were diagnosed with end stage renal disease (ESRD); were oligoanuric (oliguria of <1mL/kg/hour or anuria over 6 hours); had been on hemodialysis for at least 6 months; were alert and oriented; and, were scheduled for hemodialysis twice a week Exclusion Criteria: Patients who were pregnant; had a history of or has overt mental illness; were lethargic, disoriented, or debilitated during recruitment; and, had complicated medical conditions such as congestive heart failure and pulmonary congestion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rame John L Mina, BSN, RN
    Organizational Affiliation
    UST College of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30706521
    Citation
    Mina RJL, Lerma MB, Litan PLB, Milano AAL, Mojica ADR, Malong-Consolacion CP, Lerma EB, Macindo JRB, Torres GCS. Fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing haemodialysis: Single-blind, Randomized-Controlled Pilot Study. J Adv Nurs. 2019 Jun;75(6):1328-1337. doi: 10.1111/jan.13964. Epub 2019 Mar 18.
    Results Reference
    derived

    Learn more about this trial

    Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis

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